一次情報の記録
決定級トップライン結果
United Therapeutics: ralinepag、PAH悪化リスクを第3相で55%低減
ADVANCE OUTCOMES第3相試験が主要評価項目を達成し、臨床的悪化イベントをプラセボ比55%低減したことを示した。United Therapeuticsは2026年下半期にralinepagのNDA提出を計画しており、1日1回経口プロスタサイクリンとしてPAHの新たな標準治療となる可能性がある。
主要事実
出典の抜粋
EX-99.1 2 tm267696d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 United Therapeutics Corporation Announces Ralinepag Achieved 55% Reduction in Risk of Clinical Worsening in Pivotal Pulmonary Arterial Hypertension Study, Delivering Exceptional, Highly Statistically Significant Efficacy The phase 3 ADVANCE OUTCOMES study of ralinepag met its primary endpoint and several important secondary endpoints, including increasing odds of clinical improvement by 47%, in predominantly pre-treated patients with pulmonary arterial hypertension ( PAH ) Ralinepag has the potential to redefine the PAH treatment landscape as the first and only once-daily oral prostacyclin, combining potent receptor affinity with continuous exposure to deliver long-term, durable efficacy and disease-mitigating outcomes United T